Clinical trial · Interventional
Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel
NCT00215748CI-TRIAL-00000978terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
This study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To evaluate the feasibility of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel therapy with respect to incidence of: Grade 3/4 fluid retention
- measure
- Grade 3/4 hypersensitivity
Secondary outcomes (2)
- measure
- To evaluate the incidence of toxicity of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel with respect to: fluid retention (all grades)
- measure
- hypersensitivity (all grades)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 65 years; * breast or lung cancer patients to receive docetaxel therapy as per protocol; * corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events; * performance status ECOG 0-2; * peripheral neuropathy ≤ 1; * adequate kidney and liver functions * signed study-specific informed consent Exclusion Criteria: * Patients who have received an investigational drug within 4 weeks of registration; * Prior or concurrent malignancies (other than surgically treated carcinoma in situ; * Serious medical or psychiatric illness which would prevent informed consent; * Life expectancy \< 3 months; * Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled.
References
Publications (0)
Data not yet available
No reference posted for this study.